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Randomized, endpoint-blind, parallel group study to demonstrate the serological non-inferiority of the virosomal influenza vaccine Invivac® to the conventional subunit influenza vaccine Influvac® and the adjuvanted influenza vaccine Fluad® in elderly.

Randomized, endpoint-blind, parallel group study to demonstrate the serological non-inferiority of the virosomal influenza vaccine Invivac® to the conventional subunit influenza vaccine Influvac® and the adjuvanted influenza vaccine Fluad® in elderly.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-002225-45-SE
Enrollment
360
Registered
2004-10-26
Start date
2004-12-22
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza vaccine

Interventions

Trade Name: Invivac Product Name: Invivac Pharmaceutical Form: Injection* Other descriptive name: A/New Caledonia/20/99 (H1N1)-like strain Concentration unit: µg microgram(s) Concentration type: equal

Sponsors

Solvay Pharmaceuticals B.V.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Signed and dated informed consent - Subjects =61 years of age - The mental health must be good enough to understand the study and the informed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Known to be allergic to eggs, chicken protein, gentamicin, kanamycin, neomycin or any other constituent of the vaccines -Having fever (= 38 °C) and/or presenting with an acute infectious episode of the upper and/or lower respiratory airways -Having experienced a documented serious systemic reaction after previous influenza vaccination -Having an auto-immune disorder (RA, SLE, auto-immune thyroid disorders), taking immunosuppressive medication (such as corticosteroids) or having a disease in a terminal stage -Having received vaccination against influenza within six months prior to inclusion in the present study

Design outcomes

Primary

MeasureTime frame
Main Objective: To demonstrate that in elderly Invivac® is not inferior to Influvac® with respect to the immunogenicity of the hemagglutinin (HA) of the three viral strains contained in the vaccines.;Secondary Objective: 1. To investigate whether in elderly Invivac® is not inferior to Fluad® with respect to the immunogenicity of the HA of the three viral strains contained in the vaccines. 2. To investigate whether Invivac® meets the CPMP requirement for immunogenicity in elderly. Safety Objectives: 1. To collect data on the safety and the tolerability of Invivac® in elderly subjects. 2. To investigate whether Invivac® is superior to Fluad® with respect to local reactogenicity. ;Primary end point(s): HI antibody titers—

Countries

Germany, Lithuania, Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026